Cobra Biologics, a contract manufacturer of clinical and commercial scale biologics and pharmaceuticals, and targeted cancer therapy company BioCancell have announced an agreement to manufacture BioCancell’s BC-821 cancer drug for clinical trials.
BioCancell’s Phase I clinical trial for BC-821, scheduled to commence in 2015, is a continuity of the success of pre-clinical studies that examined the use of BC-821 as a treatment for several cancer indications such as Non-small-cell lung carcinoma, Ovarian cancer, Glioblastoma (brain tumour) and Liver metastasis.
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced March 5 the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
Contract packager Reed-Lane has put its recently installed Uhlmann Packaging Systems UPS4 MT Blister line to work in the launch of Reckitt Benkiser’s Mucinex Allergy Tablets. The new blister line can produce up to 600 blisters per minute and features a dedicated Aylward product feeder, an Uhlmann VisioTec vision system, and an in-line Uhlmann cartoner, the contract packager reported.
A new test method for detecting channel leaks, ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration, was approved at the last F02 meeting in Jacksonville, FL, and is now available from ASTM's Web site. The method is applicable for clear or opaque pouches made from materials such as film and foil. It could also be used with opaque blisters and cups with the same sensitivity, but they were not part of the initial scope.
Contract and clinical packager Almac has equipped its U.S. commercial packaging facility in Audubon, PA, with additional blister packaging technology. Capable of both thermoforming and coldforming, the new Klockner EAS blister line can produce a range of blister formats. It is suitable for low-volume runs to evaluate different packaging material combinations and cost effective stability packaging.
Freight Glove, a reusable, tamper-evident covering that can be used for air- and water-tight pharmaceutical shipments, has been designated as ‘Qualified Anti-Terrorism Technology’ under the Department of Homeland Security’s Safety Act, reports manufacturer Sentina Corp.
Eisai Inc., Woodcliff Lake, NJ, announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC). Recruitment is currently active for this multicenter study, conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group, and aims to enroll approximately 910 patients across the U.S. The primary endpoint is overall survival.
The “Pharmaceutical Packaging Equipment Market by Package Type (Blister, Strip, Bottle, Tube, Aseptic Packaging, Wrapping, Labeling & Serialization), by Product Type (Tablet, Powder, Cream, Syrup, Aseptic Liquid, Aerosol) - Global Forecast to 2018” analyzes and studies the major market drivers, restraints, and opportunities in North America, Europe, Asia-Pacific, and the Rest of the World (ROW).
Could stronger economic ties between the United States and the European Union impact medical device packaging?
The International Society for Pharmaceutical Engineering (ISPE) is inviting individuals and groups to submit conference session proposals for Pharma Expo 2014 to be held in Chicago in November.